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Clinical Trials/NCT06705283
NCT06705283RecruitingNot Applicable

Effects Of Yoga And Whole Body Vibration Training On Women With Stress Urinary Incontinence

Suleyman Demirel University1 site in 1 country39 target enrollmentStarted: November 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
39
Locations
1
Primary Endpoint
pelvic floor muscle strength test

Study Overview

Brief Summary

This study aimed to compare the effects of yoga and Whole Body Vibration Training on pelvic floor muscle strength, severity of urinary symptoms and UI-related quality of life in women with UI.

The intervention period for the study was determined as 6 weeks. It has been decided that yoga practice will be done 3 times a week for 45 minutes, and whole body vibration training will be done for 45-55 minutes. The home exercise group will perform the planned exercise protocol every day for 6 weeks.

The results of the study will be evaluated by statistical analysis as a result of the interventions and evaluations.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Between the ages of 20-60,
  • •patients with SUI or Mix UI with a predominant SUI component,
  • •patients who have not received treatment with any physical therapy modality in the last 3 months,
  • •patients who signed the informed consent form.

Exclusion Criteria

  • •Those with neurological diseases that may cause incontinence
  • •Those with prolapse
  • •Those using intrauterine devices
  • •Obesity (BMI >30)
  • •Patients with serious systemic diseases that prevent them from exercising (Cardiovascular disease, COPD, CVO and/or cancer)
  • •Patients with pure urge or mixed UI with a predominant urge component
  • •Patients with a history of thrombosis
  • •Patients who engage in high-intensity sports activities for at least half an hour at least twice a week (tennis, aerobic exercise, running, exercises with body weight).
  • •Patients with neurological or vestibular disease that may cause balance disorders
  • •Patients with grade 3 or 4 knee and/or hip osteoarthritis
  • •Patients with a history of knee and/or hip joint replacement surgery
  • •Patients with kidney or gallbladder stones
  • •Patients with acute disc herniation or spondylolisthesis

Arms & Interventions

yoga group

Experimental

This is a group where yoga and home exercise (pelvic floor muscle training) will be done together.

Intervention: yoga and home exercise (Procedure)

whole body vibration training (WBVT) group

Experimental

This is a group where whole body vibration training and home exercise (pelvic floor muscle training) will be done together.

Intervention: whole body vibration training and home exercise (Procedure)

home exercise group

Active Comparator

This is a group where pelvic floor muscle training will be done.

Intervention: home exercise group (Procedure)

Outcomes

Primary Outcomes

pelvic floor muscle strength test

Time Frame: 6 weeks

Pelvic floor muscle strength evaluation will be performed with a perineal EMG biofeedback device with a vaginal probe. After the pressure probe is inserted into the vagina, the patient will be asked to contract the pelvic floor muscles. Contractions will be repeated 3 times and averaged. The obtained value will be recorded in cmH2O.

Numerical Rating Scale

Time Frame: 6 weeks

It is used for severity of urinary incontinence. The participant was asked "How much urine do you think you leak?" The question will be asked and the student will be asked to make a mark on the chart that scores between 0-10 points.0 means no urine leakage, 10 means a lot of urine leakage.

International Consultation of Incontinence Society-Short Form

Time Frame: 6 weeks

The scale addresses the frequency of UI and how much UI affects a person's life. There are a total of 4 questions, 3 of which are included in the scoring. A total of 0-21 points are given (0: no leakage, 1-5: mild, 6-12: moderate, 13-18: severe, 21: serious urine leakage). As the score increases, the severity of UI and the impact on quality of life increase.

1 hour pad test

Time Frame: 6 weeks

• Pad test is an easy-to-perform test that determines the severity of urine leakage objectively. During the implementation of this test, the protocol established by the International Continence Society will be taken as basis. The steps of the protocol are as follows: 0. min: The weight of the clean pad is weighed. It is given to the patient. After wearing the pad, the patient is asked to drink 500 ml of water in a short time. 30 min: walking and climbing stairs 45th minute: Coughing 10 times, sitting down and standing up 10 times, picking up something from the ground 10 times, jumping 10 times, washing hands under running water for 1 minute, running for 1 minute. 60th minute: Weighing the pad taken from the patient again. After the evaluation steps are completed, the amount of urine leakage is calculated by subtracting the weight of the clean pad from the weight of the used pad.

Incontinence Impact Questionnaire-7

Time Frame: 6 weeks

There are 7 items in the scale. Items are scored between 0-3, resulting in a total score between 0-21. It is understood that as the score obtained from the scale increases, the severity of UI complaints and quality of life decrease.

Urogenital Distress Inventory-6

Time Frame: 6 weeks

It consists of 6 questions. In the scoring of the scale, there are options for each item: 0: not at all, 1: slightly, 2: moderately, 3: very much. Minimum 0 - maximum 18 points can be obtained from UDI-6. The score is determined by converting the points received into a percentage. An increase in the score obtained from the scale indicates that the level of quality of life is deteriorating.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Pinar Yasar

Principal Investigator

Suleyman Demirel University

Study Sites (1)

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